Fenestrated extremity surgical drape

ABSTRACT

A method of forming a fenestrated extremity surgical drape includes providing improved seal integrity to reduce the occurrence of pathogenic contamination at the surgical site via migration through the seal. The seal has a non-linear configuration to eliminate uneven stress concentrations commonly located at the corners of rectilinear seals. An elastomeric apertured panel can be disposed between a film panel and a fiber/film laminate panel. These layers can be joined by a heat sealing operation along two spaced apart concentric seal locations ringing the aperture and a fenestration in the laminate panel. The assembly can then be affixed by adhering the underside(s) of one or more panels to a base drape, which has an opening aligned with the aperture and fenestration.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. application Ser.No. 11/245,882, filed Oct. 7, 2005, the disclosure of the priorapplication is hereby incorporated in its entirety by reference.

STATEMENT OF FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

BACKGROUND OF THE INVENTION

1. Technical Field

The present invention relates to the field of medical items used duringsurgery. In particular, the invention pertains to an improvedfenestrated surgical drape.

2. Description of the Related Art

Surgical drapes are used during surgery to create a sterile barrieraround the surgical site. Surgical drapes having fenestrations, oropenings, that are specifically designed for certain surgical proceduresare well known. Typically, such drapes are structured with pre-shapedand pre-sized openings in contemplation of providing surgical access toa specific anatomical site of the patient. In this category of drape,the fenestration or opening is used for surgical access.

Another type of fenestrated drape is that which is configured toaccommodate the anatomy through the fenestration but also to create thesterile field between the body portion containing the surgical site andthe remainder of the patient's body via a conformable aperture. Thus, inthis type of surgical drape, the fenestration provides surgical accessand the aperture provides surgical isolation by sealing against thepatient's body. One example of this type of fenestrated drape is one inwhich the aperture is elastomeric and generally dimensioned toaccommodate a limb or other anatomical extension. Thus, when the limb isinserted through the opening, minor variations in natural geometry areaccommodated by the flexibility of the elastomeric material. Theelastomeric material further forms a tight seal circumscribing theanatomy, thereby forming a sterile barrier separating the surgical sitefrom the remainder of the patient's body. Elastomeric aperture typefenestrated drapes afford the advantage of creating a secure air andfluid barrier between the sterile and non-sterile sites withoutrequiring the use of supplemental tourniquets, taping and the like.

Current such fenestrated drapes are constructed by superimposing panelsand portions of materials to seal the apertured panel to the base drape.The seal between the layers is conventionally formed using adhesives,such as double-sided adhesive areas to create a “square” seal around theperimeter of the aperture and the opening in the base drape.

One problem associated with current fenestrated surgical drapes is therisk of compromising the sterile field at the surgical site. Inparticular, although the elastomeric fit circumscribing the limb orother anatomical extension reduces the likelihood of contaminationthrough the immediate area around the aperture, the perimeter of theapertured panel is still nevertheless dependent upon the adhesivebetween layers for the microbial barrier. Fluid, for example, canpotentially transport across the adhesive seal between the layerssurrounding the apertured panel.

Another problem with current fenestrated drapes, particularly withapertured panels incorporated into the drape, involves structuralintegrity. That is to say, current designs experience stress pointsduring their use at certain locations around the perimeter of theattachment sites. On occasion, the stress results in separation of theseams at these sites, thereby compromising the sterile field surroundingthe surgical site. Accordingly, the risk of exposure and infection atthe surgical site is increased.

There is thus a need in the field of surgical drapes for a drape havingan aperture with improved structural integrity and microbial barrierproperties at the seal.

SUMMARY OF THE INVENTION

The invention provides a fenestrated surgical drape for use with bodyextremities that has improved seal integrity to reduce the occurrence ofpathogenic contamination at the surgical site via migration through theseal. The seal can have a non-linear configuration that eliminatesuneven stress concentrations commonly located at the corners ofrectilinear seals. A heat sealing operation can be used to create two ormore spaced apart seal locations to provide redundant, higher integritysealing with greater uniformity throughout the seal.

Specifically, one aspect of the invention provides a fenestratedsurgical drape having a base drape and a multi-panel assembly includinga sealing panel with an opening, an apertured panel and a fenestratedpanel. The panels are aligned so that the opening, aperture andfenestration are superimposed in registration with one another, and thencollectively joined to one another to form a continuous fluid imperviousseal surrounding the aperture and fenestration. The panel assembly isfixed to the base drape about the entire perimeter of the base drapeopening so that it is superimposed in registration with the sealingpanel opening, the aperture and the fenestration.

The apertured panel can be made of an elastomeric material so that itcan stretch, conform and seal against an extremity of the body. In thisway, the present invention provides a surgical drape suited for use witha body extremity to form a sterile barrier separating the surgical sitefrom the remainder of the patient's body without the need forsupplemental isolation devices.

The apertured panel can be disposed between the sealing panel and thefenestrated panel. All three panels, once properly aligned, can bejoined together as an assembly. The assembly can then be fixed to thebase drape such as by an adhesive between one or more panels and thebase drape about the opening of the base drape.

Multiple distinct seal regions can be provided about the sealing panelopening, the aperture and the fenestration, which can be effected byheat sealing operation using heat and pressure to thermally andmechanically bond the panels together. Non-linear seal regions eliminatethe hot spots associated with rectilinear seals formed by theapplication of heat. For example, two concentric circular seal regionscan ring the aperture and fenestration, the seal regions being spacedapart some radial distance. A more uniform seal is achieved in thismanner by eliminating the hot spots associated with corners, and byemploying multiple seal regions, individually of smaller dimension thanif a single large seal. With smaller sized individual seals, smallerdimensioned dies can be used, the wall(s) of which can be heated moreuniformly so that cold spots therein are avoided. Moreover, multipleseal regions, each individually surrounding the aperture and thefenestration and the outer seal region(s) surrounding the inner sealregion(s), provide redundant sealing to better reduce the likelihood ofcontaminants breaching the seal.

Another aspect of the invention provides a fenestrated surgical drape,suitable for use with human extremities, including a base drapesubstrate and a multi-layer panel assembly including a film sealingpanel, an elastomeric apertured panel and a fiber/film fenestratedpanel. The assembly can be affixed to the base drape with an adhesive,and the base drape can itself be an assembly of substrates, such asnon-woven fibrous material and film, for example aspunbonded/film/spunbonded laminate. The surgical drape can thus bearranged in the order of the spunbonded/film/spunbonded base drape,adhesive, film panel, elastomeric panel and fiber/film panel with itsfilm side facing the elastomeric panel.

Another aspect of the invention provides a method of making afenestrated surgical drape. The method includes forming a panel assemblyhaving a sealing panel with an opening, a fenestrated panel defining afenestration, and an apertured panel defining an aperture and disposedbetween the sealing and fenestrated panels. The panels are superimposedsuch that the sealing panel opening, the fenestration and the apertureare aligned in registration. The panels are joined by heat sealing alonga seal surrounding the aperture and fenestration. The panel assembly isaffixed to the base drape so that the sealing opening, the fenestrationand the aperture are superimposed in registration with the base drapeopening.

The above and still other advantages of the invention will be apparentfrom the detailed description and drawings. What follows are one or morepreferred embodiments of the present invention. To assess the full scopeof the invention the claims should be looked to as the preferredembodiment(s) are not intended to be exclusively within the scope of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a patient on a surgical table draped ina fenestrated extremity surgical drape according to the presentinvention;

FIG. 2 is an exploded perspective view of a panel assembly of thesurgical drape shown in FIG. 1;

FIG. 3 is an exploded perspective view of the panel assembly of FIG. 2and a base drape;

FIG. 4 is a sectional view taken through an aperture along line 4-4 ofFIG. 3 showing the surgical drape of the present invention before thepanel assembly is affixed to the base drape;

FIG. 5 is a sectional view similar to FIG. 4 albeit with the panelassembly affixed to the base drape;

FIG. 6 is an enlarged view showing the layers of material in a preferredembodiment of the surgical drape; and

FIG. 7 is a plan view of the panel assembly showing a preferreddouble-ring seal configuration thereof.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S)

The present invention pertains to a fenestrated surgical drapeparticularly suited for isolating anatomical extremities from otherparts of the body during a surgical procedure. The surgical drape hasimproved liquid and fluid resistance at the seal surrounding thefenestration. In one preferred embodiment of the invention shown anddescribed in detail herein, seal strength and integrity are enhanced bya non-linear seal configuration, multiple narrow, redundant seal regionsand the presence of material suitable for heat sealing.

Referring now to FIGS. 1-6 of the drawings, the invention provides asurgical drape 10 including a base drape 12 and a fenestration panelassembly 14, which is made of a sealing panel 16, an apertured panel 18and a fenestrated panel 20. The base drape 12 is affixed to the panelassembly 14 by an adhesive 22 about the entire periphery of an basedrape opening 24. Six cord and tube holding tabs 50 are affixed toeither the panel assembly 14 or the base drape 12, for example three ateach short end of the fenestrated panel 20, with holes for retainingtubing and/or electrical cords to prevent them from entering the sterilefield.

As shown in FIGS. 1 and 3, the base drape 12 is a large flexible sheetof material, generally rectangular in the shown embodiment but it can beany suitable shape, provided it is large enough to cover a human body ora sufficient portion of the body adjacent the surgical site to assist increating a sterile field at the surgical site. The base drape 12 has theopening 24 generally in a central region near the center of the drape,however, it could be located near off center near any peripheral edge ofthe drape.

The base drape 12, and the cord tabs 50, can be made of any of a varietyof suitable commercially available medical fabric materials. Suchmedical fabric materials known in the surgical field include withoutlimitation non-woven fabrics. “Non-woven fabrics” as used herein refersto a single web, or an assembly or laminate of multiple webs, formed ofindividual randomly laid fibers, for example using a spunlaid,thermobonded, spunbonded, meltblown or bonded carded web process. Alaminate of non-woven fabrics is one conventional material in thesurgical field that could be used for the base drape 12. Aspunbonded/meltblown/spunbonded laminate of polypropylene fibers is oneexample. Another example of a suitable medical fabric material for thebase drape 12 is a combination non-woven fabric and film in which aliquid impervious polymer film is disposed between two non-woven layers.This preferred embodiment is shown in FIG. 6. Such aspunbonded/film/spunbonded laminate material is commercially availableas Tiburon™ from Ahistrom Corporation of Helsinki, Finland.

In any of these composite sheet materials, the individual web layers canbe joined together throughout some or all of the surface area and/oralong the periphery using any suitable mechanical, thermal, or chemicalbonding process, such as point or pattern bonding by the application ofheat and/or pressure to the webs. The fibers comprising the various webscan be hydrophilic (liquid absorbing) or hydrophobic (liquid repelling)depending on the material selected. Particularly when a liquidimpervious layer is used, such as an inner polymer film, the outerfacing layer can be made of hydrophilic fibers, or treated with asurfactant to be absorbent. When a liquid impervious layer is not usedin the make up of the base drape 12, the exposed outer layer of the basedrape 12 can made of hydrophobic fibers, or treated to be liquidrepelling, so that blood or other body fluids present during surgery donot absorb into the base drape 12 and migrate through the material intocontact with the patient's body.

The base drape 12 can be constructed of outer webs of different colorsor indicia, or a single web with different colors or indicia on eachside, to provide visual indication of the difference in material orsurface treatments between the sides of the drape. This would help thepractitioner identify the proper side to face the patient, for example,if a softer or hydrophobic web was used at the underside of the basedrape.

As mentioned, the panel assembly 14 includes three panels. When thepanel assembly 14 is attached to the base drape 12, the sealing panel 16is adjacent the base drape 12 and an opening 26 in the sealing panel 16is superimposed in registration with the base drape opening 24. Thesealing panel opening 26 should be sized slightly larger than the basedrape opening 24 so that is circumscribes the base drape opening 24 whenassembled.

The sealing panel 16 is preferably a flexible sheet suitable for heatand pressure bonding by heat sealing to at least the other panels of thefenestration assembly 14. A thin polymeric film, such as made ofpolyethylene, polypropylene, polyester, polyvinylchloride andcombinations thereof, can be used as the sealing panel 16 given itsability to bond to other chemically compatible polymeric materials, andparticularly non-woven polymer fabrics and elastomers. As mentioned,polymeric films are also preferable because of their liquid imperviousproperty. Any suitable film thickness can be used with a preferred rangebeing 2-5 mils.

The intermediate layer of the panel assembly 14 is the apertured panel18, which defines an aperture 28. The aperture 28 is superimposed inregistration with the sealing panel opening 26 (and opening 30 of thefenestrated panel discussed below) when the panel assembly 14 isassembled. The apertured panel 18 in the preferred embodiment is astretchable, conformable material suitable to provide a tight sealagainst the anatomical extremity. Moreover, the aperture itself has asmooth curved inner peripheral edge to avoid gaps between it and theextremity as well as to eliminate areas of increased stressconcentrations, as may be present in corners, that can lead to tearingof the aperture edge and disturb the seal with the extremity. Theaperture 28 has the least dimension of any of the openings (of whatevertype) in the other components of the drape 10, which again is to effecta tight seal with the extremity.

The apertured panel 18 can be made of any suitable sheet havingelastomeric properties suitable for surgical applications, includingwithout limitation natural and synthetic rubbers, and being chemicallycompatible for bonding to the sealing panel 16 and the fenestrated panel20. A suitable grade of thermoplastic elastomer marketed under theKraton® brand by Kraton Polymers of Houston, Tex. can be used for theapertured panel 18.

The last layer of the panel assembly 14 is the fenestrated panel 20,which defines a fenestration 30 sized larger than the aperture 28 andthe base drape opening 24, but slightly smaller than the sealing panelopening 26 such that its inner peripheral edge is slight radially inwardthereof. In one preferred form, the fenestrated panel 20 can have astrength component, such as a layer of any suitable natural or syntheticmedical fiber material, preferably a non-woven fabric, and morepreferably a non-woven fabric as used in the outer layer of the basedrape 12 such as a spunbonded web of hydrophilic fibers or fibers havinga surface treatment to be absorbent, and can have a sealable component,preferably in the form of a polymer film layer at the underside (facingthe fenestration) of the non-woven fabric layer, which is compatible forbonding with the elastomeric aperture panel 18. FIG. 6 illustrates thispreferred construction of the fenestrated panel 20.

A suitable bonding agent or technique can be used to affix the panelassembly 14 to the base drape 12. Such a bonding agent can be adouble-sided tape or a liquid adhesive, such as a hot melt adhesive,that is chemically compatible with both of the mating materials. In onepreferred form, a liquid adhesive is applied in the margin of theperimeter along the film side of the fenestrated panel 20 and along theunderside of the apertured panel 18 near its perimeter. At least theadhesive at the perimeter of the fenestrated panel 20 surrounds theentire base drape opening 24 when the panel assembly 14 is adhered tothe base drape 12. The adhesive could be replaced by another bondingtechnique, such as ultrasonic welding.

It should be noted that the openings 24 and 26, the fenestration 30 andthe aperture 28 can be of any suitable size and configuration suitablefor receiving an anatomical extremity, such as a human arm or leg. Theopenings 24, 26 and the fenestration 30 are preferably larger than atypical extremity and the aperture 28 is preferably sized smaller thanthe typical extremity so that it will stretch as it is fit about theextremity and create an air and liquid impervious seal. The openings,fenestration and aperture are depicted as circular, however, they can beany suitable shape, including without limitation oblong, any rectilinearshape or pear/tear-drop shape with asymmetric wider and narrower ends,as may be desired to meet particular dimensions of specific anatomicalsites.

An important aspect of the surgical drape 10 of the present invention isthe seal arrangement of the layers of the panel assembly 14. Severalfeatures of the seal and sealing technique serve to improve theintegrity and strength of the seal and thereby improve its effectivenessas a barrier to contaminants. Briefly, these features include thenon-linear configuration of the seal, the use of multiple, narrow sealregions circumscribing the aperture and fenestration and the use of aheat sealing technique to join the panels with the application of heatand pressure.

More specifically, one preferred embodiment of the seal 40 is shown intop view in FIG. 7. As can be seen, in this embodiment the seal 40 isformed by two distinct concentric circular regions 42 and 44circumscribing the fenestration 30, as well as the opening 26 of thesealing panel 16 and the aperture 28. The two seal regions 42 and 44 arespaced apart, with the inner seal region 42 being spaced a radiallydistance from of the inner peripheral edges of the respective sealingand fenestrated panel openings 26 and 30 and the outer seal region 44being spaced a radial distance from the inner seal region 42.

The seal 40 thus joins all three panels 16, 18 and 20 of the panelassembly 14 with a liquid impervious thermally and mechanically bondedseal surrounding the opening 26, the aperture 28 and the fenestration30. The seal provides generally uniform bonding throughout the entireseal regions primarily due to two factors, namely, its non-linearconfiguration and the use of multiple, narrow seal regions. Morespecifically, the non-linear configuration eliminates the “hot spots” orareas of increased temperature distribution that often occur at theintersection of linear segments of the seal. Since the seal regions arecircular there are no linear segments, and thus no hot spots, resultingin a generally even temperature distribution along the long, herecircular, dimension of the seal regions. The use of narrow seal regionsreduces or eliminates the temperature variance that can occur in thewall(s) of the sealing element, which can have a lower temperature atthe wall center than at the wall peripheral edges, particularly withlarger wall thickness dimensions. By using sealing elements with lesserwall thickness dimensions, the entire wall(s) can be heated moreuniformly. Since the temperature distribution is more evenly distributedthroughout the entire wall thickness, uniform temperature distribution,and thus bonding, can be established along the short (radial) dimensionof the seal.

Another feature of the seal 40 that improves its barrier effectivenessis that a redundant seal is established by virtue of having two distinctseal regions 42 and 44. Since each seal region 42 and 44 surrounds thesealing panel opening 26, the aperture 28 and the fenestration 30entirely, each independently works to provide a barrier. If an unbondedpoint in the inner seal region 42 were to occur, the outer seal region44 could provide barrier resistance and vice versa.

Moreover, by using two narrow seal regions, for example two ¼ inch thickseal regions instead of one ½ inch thick seal region, and spacing themapart, the total seal bonding area is increased, by virtue of the largerdiameter of the outer seal region 44 caused by spacing the outer sealregion radial outward.

To summarize, the seal has more uniform bonding throughout the sealregions in the short radial dimensions. The uniformity of the bonding inthe long circular dimensions of the seal regions is improved as well dueto the non-linear configuration eliminates hot spots. Further, built-inredundancy of the two seal regions improves the overall integrity of theseal should bonding of one of the regions become compromised. And, theoverall bond area is increased. The result is a liquid impervious sealwith improved barrier properties to contaminants.

The seal 40 is formed by thermally and mechanically bonding the panelsof the panel assembly 14 together with heat and pressure using a heatsealing operation. Prior to the heat sealing operation, the panels 16,18 and 20 are formed by manual or automated processes, for example, byseparately unwinding spools of web material and then forming theopenings, fenestration and aperture by independent roll, die or othercutting operations. The fenestrated panel can be cut from a non-wovenfiber/film laminate web and the base drape can be cut from aspunbonded/film/spunbonded laminate web. The webs are cut to defineindividual panels of the desired size and shape. The panels of the panelassembly are bought together in the proper order with the film side ofthe fenestrated panel facing the apertured panel and the sealing panelbeing at the other side of the apertured panel. The fenestration and thesealing panel openings are superimposed in registration with theaperture and the panels are joined by forming the aforementioned heatseal about the fenestration. A suitable heat sealing machine, such asthat manufactured by Therm-O-Seal, of Mansfield, Tex., can be used. Inone preferred process, the seal is formed by applying pressure in therange of about 60-80 psi at 200-350.degree. F. for a cycle time ofbetween about 4-5 seconds.

The cord tabs can then be affixed with adhesive to the film side of thefenestrated panel. And, the panel assembly can then be affixed to thebase drape by applying a line of adhesive along the perimeter of thefilm side of the fenestrated panel as well as to the underside of theapertured panel (in a circular pattern) and then pressing the panelassembly against the base drape with the sealing panel opening, apertureand fenestration superimposed in registration with the base drapeopening. The assembled surgical drape is then folded in a suitableconfiguration, such as a fan and/or roll folds, and suitable indicia(such as unfolding instructions) can be printed or stamped onto thefolded drape.

The general procedure for using the surgical drape 10 of the presentinvention according to one embodiment of the invention is as follows.The patient is laid onto an operating table facing up or in the proneposition in preparation for surgery. The drape is unpackaged, unfoldedand laid over the patient. The drape is positioned so that the panelassembly 14 is near the extremity of interest. The drape is held onopposite sides of the fenestration and is placed onto the extremity asthe extremity is pulled through the base drape opening 24, the sealingpanel opening 26, the aperture 28 and the fenestration 30, all of whichare in alignment. The drape is positioned up the extremity past thesurgical site with the aperture 30 sealing against the extremity near oradjacent the surgical site. The drape is re-oriented as needed to ensurethat the rest of the patient's body is covered, or at least a sufficientportion thereof to provide for a sterile field at the surgical site. Ifnecessary, one or more additional drapes, with or without fenestrationsand apertures, may be used to cover other non-surgical areas of thepatient.

The invention has been described herein with reference to variousspecific and preferred materials, embodiments and techniques. It shouldbe understood that many modifications and variations to such materials,embodiments and techniques will be apparent to those skilled in the artwithin the spirit and scope of the invention. Therefore, the inventionshould not be limited by the above description, and to ascertain thefull scope of the invention, the following claims should be referenced.

INDUSTRIAL APPLICABILITY

The invention is useful in fenestrated surgical drapes having anelastomeric apertured panel as part of their construction and designedfor use in surgical procedures on limbs and other anatomical extensions.

1. A method of making a fenestrated surgical drape, comprising: forminga panel assembly including a fenestrated panel defining a fenestration,an apertured panel defining an aperture, and a sealing panel having anopening, wherein the apertured panel is disposed between the sealingpanel and the fenestrated panel; superimposing the panels such that thesealing panel opening and the fenestration are in registration with theaperture; sealing the fenestrated, apertured and sealing panels along anon-linear seal path surrounding the fenestration and the aperture; andaffixing the panel assembly to a base drape with the aperture,fenestration and sealing panel opening superimposed in registration withan opening in the base drape.
 2. The method of claim 1, wherein thesealing panel is a film, the apertured panel is an elastomeric sheet,and the fenestrated panel is a fiber/film laminate.
 3. The method ofclaim 2, wherein the sealing includes a heat sealing operation.
 4. Themethod of claim 1, wherein the seal path includes at least two spacedapart seal regions
 5. The method of claim 4, wherein the seal pathdefines two radially spaced concentric circles.